Minnesota Supreme Court backs families over newborns' blood storage

Adding to a national debate that pits privacy concerns against medical researchers, the Minnesota Supreme Court ruled Wednesday that a lower court must reconsider a challenge to the state Health Department's practice of storing blood samples from newborns indefinitely.

Attorneys for plaintiffs in the case said the ruling means the Health Department might be forced to destroy nearly 1 million blood samples that researchers have drawn on for limited medical research purposes since 1997.

"If they don't have written informed consent, they have to destroy these blood samples and the test data," said Scott Kelly, a lawyer for the plaintiffs.

"This case has national significance. Every state in the U.S. has a newborn screening statute...and many states do exactly what Minnesota has been doing with these samples."

Health Department officials, however, said it was too early to assess broader implications from the ruling.

At issue are blood samples collected from babies as part of the Health Department's newborn screening program. The samples are tested for disorders, but the Health Department retains for other purposes the excess blood samples and test results.

"This important public health program protects Minnesota babies from serious congenital and heritable disorders," said Dr. Ed Ehlinger, the state health commissioner, in a statement Wednesday.

The screening program requires blood samples to be taken from children by the fifth day after birth.

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The sample consists of a few blood drops collected on a specimen card.

The card is sent to the Health Department, and the sample is tested for disorders. The screening typically uses about 70 percent of the sample, but the Health Department keeps the remainder indefinitely unless there is a specific request to have it destroyed.

"More than 50,000 blood samples have been used in studies for purposes beyond the initial screening of the newborn children," Justice Helen Meyer said in the court's ruling. "These studies have included developing new tests and assuring the quality of existing tests. Blood samples have also been used for studies unrelated to the newborn screening program."

Two years ago, nine families sued the state in Hennepin County over the retention and use of the blood samples. The plaintiffs don't have a problem with the newborn screening program, Kelly said, but they have privacy concerns about the retention of the samples.

"The state Department of Health violated the public trust here," Kelly said. "We need to rein it in, and there needs to be an open public discussion about...what are we going to allow the government to do or not do with our children's DNA."

The retained samples are used for quality-control testing in which babies' names and dates of birth are not revealed, the Health Department says on its website.

In certain cases, outside researchers may use the samples to develop a new newborn screening test or to better understand diseases, the department says, but the baby's name and identifying details are removed.

The Supreme Court ruled Wednesday, however, that those protections aren't enough.

"Unless otherwise expressly provided by law, the department must have written informed consent to collect, use, store or disseminate those samples," the ruling said.

In recent years, controversy over the practice of storing such samples has grown.

In 2009, Texas agreed as part of a legal settlement to destroy all samples it stored from the state's newborn screening program. The Houston Chronicle reported at the time that Texas would end up destroying about 5.3 million blood samples as a result.

Texas now has a law that expressly authorizes the storage and specified uses of samples unless parents object.

This year, doctors writing in the medical journal Pediatrics said state laws and policies governing the storage and use of the samples ranged from explicit to nonexistent, leaving many parents ill-informed about how their babies' blood might be used.

"The lack of transparency on the part of states...may undermine the public's trust in state newborn screening programs and the research enterprise," the doctors said.

The Minnesota Supreme Court ruling rejected the state's argument that it could retain the samples under an exception to the state's Genetic Privacy Act. Previously, Hennepin County District Court dismissed the families' lawsuit and the Court of Appeals affirmed that decision.

The case now goes back to the district court for consideration of what remedies might be available to the plaintiffs. While a majority of justices ruled to send the case back to the lower court, three judges said they agreed with parts of the ruling and dissented with other parts.